FDA Announces that Hepatitis C Drugs Could Reactivate Hepatitis B
Despite all the promise of the new drugs on the market to treat hepatitis C virus (HCV), the U.S. Food & Drug Administration (FDA) recently required a “Boxed Warning,” its most prominent warning, about risks associated with these high-cost treatments.
Using data collected in its adverse event reporting system (FAERS) and from published literature, the FDA identified 24 cases of reactivation of hepatitis B virus (HBV) in patients who were co-infected with HCV/HBV. In these 24 cases, two patients died, and one required a liver transplant. As a result, healthcare professionals are now being directed to screen all patients for HBV before treating them with direct-acting antivirals (DAA).
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HBV, which has no known cure, can go dormant, and patients are often unaware or forget that they have it. In addition, because patients with HBV co-infection were excluded from the clinical trials, HBV reactivation was not reported as an adverse event when these medications were submitted for approval. According to the FDA statement, “The trials excluded [HBV] patients in order to specifically evaluate the safety of DAAs, including their effects on the liver, in patients infected with only HCV and without the presence of another virus which affects the liver.”
All of the DAAs that do not require interferon are included in the warning: Sovaldi, Harvoni, and Gilead Sciences’ newest, Epclusa; Daklinza from Bristol-Myers Squibb; Technivie, Viekira Pak, and Viekira Pak XR from AbbVie; Olysio from Janssen; and Zepatier from Merck & Co. For a typical 12 week treatment, with one of these DAAs, payers are looking at costs ranging from $54,000 to $94,000 per person.
With these new concerns, payers are likely to start scrutinizing patient outcome data even more closely to ensure that their money is being well spent and that patients are improving on these therapies. Therefore, pharmacy staff should ensure that they are appropriately documenting clinical outcomes and adverse events so that risks are minimized and more positive outcomes are achieved.
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